Safety Study of Mesenchymal Precursor Cells in Type 2 Diabetes
A Randomized, Placebo-Controlled Dose-Escalation Study to Assess the Safety and Tolerability of a Single Intravenous Infusion of Allogeneic Mesenchymal Precursor Cells (MPCs) in Patients With Type 2 Diabetes Sub-optimally Controlled on Metformin
1 other identifier
interventional
61
1 country
18
Brief Summary
This study is being conducted to assess the overall safety and tolerability of a single intravenous infusion of three doses of Mesenchymal Precursor Cells versus Placebo in subjects with Type 2 Diabetes inadequately controlled on Metformin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 type-2-diabetes
Started Apr 2012
Longer than P75 for phase_1 type-2-diabetes
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 9, 2012
CompletedFirst Posted
Study publicly available on registry
April 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedJune 2, 2020
June 1, 2020
1.5 years
April 9, 2012
June 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Primary objective of the study is to assess the safety and tolerability of MPC therapy
Outcomes include the measurement of the following safety parameters: * Adverse events and serious adverse events(including hypoglycemia) * Vital signs (BP, HR, RR, O2 saturation) * Physical examinations * Results of clinical laboratory tests (hematology, biochemistry, and urinalysis, flow cytometry Class I and Class II PRA % with specificity, antibovine and antimurine antibody analysis) * Pulmonary function test * Electrocardiograms * Chest X-ray * Fundus oculi examination
116 Weeks
Study Arms (3)
Cohort 1
EXPERIMENTALMPC dose 1 or Placebo
Cohort 2
EXPERIMENTALMPC dose 2 or Placebo
Cohort 3
EXPERIMENTALMPC dose 3 or Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Male and female subjects who are ≥ 18 and ≤ 80 years old
- Subjects diagnosed with type 2 diabetes at least one year prior to Screening and receiving a stable, therapeutic dose of metformin \> 1500 mg/day according to local prescribing information for at least 3 months prior to Screening or the highest tolerated dose \> 1000 mg/day documented in the subject's history
- HbA1c \> 7.0% and \< 10.5% at Screening
- C-peptide \> 0.8 ng/mL at Screening
- Body mass index (BMI) \> 22 and \< 45 kg/m2 at Screening
- Body weight \< 150 kg at Screening
You may not qualify if:
- Prior participation in any stem cell study
- Women who are pregnant, intending to become pregnant during the study period or currently lactating
- History of active substance abuse (including alcohol) within the past 2 years. Current alcohol abuse is defined as daily consumption of \>3 alcoholic beverage. Current cigarette smoking \> 10 cigarettes per day
- Severe hypoglycemia (defined as requiring third party assistance) or repeated and/or frequent hypoglycemia episodes (\> 2 episodes/week) within one month prior to Screening
- Patients receiving treatment for type 2 diabetes with diet and exercise alone, insulin therapy within 6 months of Screening except if used transiently for \< 7 days for intercurrent illness or any other anti-diabetic medication except metformin within 3 months of Screening
- Any concurrent medical condition/disorder or clinically symptomatic cardiovascular, gastrointestinal (including pancreatitis), renal, hematological, pulmonary, acute or chronic infectious disease, active retinal disease, or other disorder which in the Investigator's opinion would interfere with the subject's ability to complete the trial, would require administration of treatment that could affect the interpretation of the safety and efficacy variables or would preclude safe involvement in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mesoblast, Ltd.lead
Study Sites (18)
SC Clinical Research
Garden Grove, California, 92844, United States
Diabetes Research Institute
Miami, Florida, 33136, United States
Compass Research
Orlando, Florida, 32806, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Tulane University Medical Center
New Orleans, Louisiana, 70112, United States
Big Sky Clinical Research
Butte, Montana, 59701, United States
Desert Endocrinology Clinical Research Center-Henderson
Henderson, Nevada, 89052, United States
Alliance Against Diabetes/AAD Clinical Research
Las Vegas, Nevada, 89101, United States
Active Practices and Research
Newington, New Hampshire, 03801, United States
The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219, United States
Providence Health Partners - Center for Clinical Reseach
Dayton, Ohio, 45439, United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230, United States
West Houston Clinical Research Services
Houston, Texas, 77055, United States
Paragon Research Center
San Antonio, Texas, 78205, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
National Clinical Research - Norfolk, Inc
Norfolk, Virginia, 23502, United States
National Clinical Research - Richmond, Inc.
Richmond, Virginia, 23294, United States
Capital Clinical Research Center
Olympia, Washington, 98502, United States
Related Publications (1)
Skyler JS, Fonseca VA, Segal KR, Rosenstock J; MSB-DM003 Investigators. Allogeneic Mesenchymal Precursor Cells in Type 2 Diabetes: A Randomized, Placebo-Controlled, Dose-Escalation Safety and Tolerability Pilot Study. Diabetes Care. 2015 Sep;38(9):1742-9. doi: 10.2337/dc14-2830. Epub 2015 Jul 7.
PMID: 26153271DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
K Segal, PhD
Mesoblast, Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2012
First Posted
April 12, 2012
Study Start
April 1, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2015
Last Updated
June 2, 2020
Record last verified: 2020-06